TEG002 for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Gadeta B.V.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single arm, open-label, multicenter phase I study to assess the safety, tolerability and preliminary efficacy of autologous T cells transduced with a specific γδTCR, i.e. TEG002, in a dose escalation and expansion study in relapsed/refractory Multiple Myeloma patients. The study will comprise of a Dose Escalation Segment and an Expansion Segment. The study consists of a screening period, leukapheresis of mononuclear cells, and conditioning chemotherapy, followed by TEG002. All subjects continue to be followed regularly for safety and efficacy assessments until 1 year after TEG002 administration.

Research Team

Eligibility Criteria

This trial is for adults with relapsed or refractory Multiple Myeloma who have a life expectancy of at least 3 months and are in relatively good health (ECOG status 0 or 1). Participants must be able to use contraception and have recovered from previous therapies. Those with amyloidosis, uncontrolled infections, recent other cancers, severe heart/kidney issues, active CNS disease, or certain blood clots can't join.

Inclusion Criteria

My bone marrow is working well.

My side effects from previous treatments are mild or gone.

You are expected to live for at least 3 more months.

See 6 more

Exclusion Criteria

I have had a stem cell transplant from a donor.

I have been diagnosed with amyloidosis.

I do not have any infections that are not responding to treatment.

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Treatment Details

Interventions

TEG002 (CAR T-cell Therapy)

Trial OverviewThe study tests TEG002 cells in patients whose Multiple Myeloma has returned after treatment. It's an open-label phase I trial that includes cell collection from the patient (leukapheresis), chemotherapy preparation, followed by TEG002 administration. Patients will be monitored for safety and effectiveness for one year post-treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Single Arm, Open labelExperimental Treatment1 Intervention

This is a single arm, open-label, multicenter phase I study with a dose escalation and an expansion segment. For the Dose escalation segment, 3-9 patients per dose cohort will receive: * Dose level 1: Low * Dose level 2: Medium * Dose level 3: High For the expansion segment, additional patients may be enrolled until a maximum of 20 patients have received the recommended dose